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U.S. Department of Health and Human Services

Medical Devices

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Information on Medical Cribs Used in Homes and Child Care Settings

On December 28, 2010, the Consumer Product Safety Commission (CPSC) issued a final rule identifying new safety standards for consumer cribs. The CPSC crib standards, which establish improved safety requirements, including a ban of drop-side rail designs for consumer cribs, took effect for consumer crib manufacturers and retailers on June 28, 2011 and child care centers, family child care homes, and places of public accommodation (such as hotels) on December 28, 2012. However, current FDA regulation allows pediatric medical cribs used in hospitals to keep the drop-side rail feature because it is critical for providing appropriate medical care to sick children.

The FDA realizes that in certain, uncommon situations pediatric medical cribs with drop-side rails may need to be used outside of a health care setting. The FDA is working on a draft rule that will allow pediatric medical cribs with drop-side rails to be used outside of a health care setting when it is prescribed by a physician.

Also, the draft rule will propose that slat width and mattress flammability requirements be consistent with those established by the CPSC and will propose separate safety requirements for pediatric medical cribs and pediatric medical bassinets, which are currently regulated as pediatric hospital beds.

The purpose of the draft rule is to:

  • provide continued access to drop-side medical cribs in a home, child care or other facility when it is medically necessary;
  • further reduce potential risks posed by entrapment or fire;
  • align applicable safety requirements for pediatric medical cribs with those of the consumer cribs; and
  • provide manufacturers with clarity about FDA's safety expectations by providing more specific design requirements for pediatric medical cribs and bassinets used in hospitals.

The public will have an opportunity to comment on the draft rule before the FDA develops and publishes the final rule. The FDA anticipates issuing the draft rule in 2013.

The FDA is aware that some child care facilities and family child care homes already have one or more pediatric medical cribs in their facility. Currently, FDA's proposed rule regarding prescription-use of medical cribs outside of health care settings is in the planning stages. The FDA anticipates the process of publishing a draft for comment then finalizing the rule will take at least a year. In the meantime, we encourage facilities with questions about pediatric medical cribs to contact their local or state licensing agencies to find out how the CPSC's final rule affects them.